Injection Recalled After Manufacturer Halts Quality Program

Viatris Inc is recalling 2736 boxes of Levsin injection distributed by Meda Pharmaceuticals Inc, a Viatris company. According to the June 14, 2023, US Food and Drug Administration (FDA) Enforcement Report, the product is being recalled because the manufacturer discontinued its quality assurance program.

The recall affects Levsin injection (hyoscyamine sulfate injection), 0.5 mg per mL in water for injection, packaged in a box of five 1-mL ampules (NDC 0037-9001-05), from lot 101241A (Exp 10/23). The product was sent to 10 distributors that may have further distributed the product to the retail level.

Viatris voluntarily initiated the recall May 25, 2023. The FDA designated the recall Class II on June 5, 2023. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Levsin injection is a prescription anticholinergic/antispasmodic drug with several indications, including as adjunctive therapy in the treatment of peptic ulcer, irritable bowel syndrome, neurogenic bladder and bowel disturbances, as well as for use in anesthesia and urology procedures.